Key Factors for Successful Development and Implementation of Electronic Data Capture in Clinical Trials
Independent thesis Advanced level (degree of Master (Two Years)), 20 credits / 30 HE creditsStudent thesis
Drug development in general and clinical trials in particular is expensive and time consuming processes. One mandatory procedure in clinical trials are data collection, about 15 years ago almost all data were collected with a paper based approach but with new digitalised technology for data collection the process were about to become more efficient in regard to time, cost and quality of data. However the adoption rate of these systems for data collection were much lower than anticipated and most previous research points toward poorly developed products as the main reason for the adoption failure. Nevertheless, these systems have become more user friendly and efficient and today almost all studies use Electronic Data Capture (EDC) as the primary method for data collection. This project aim to investigate if the reason for the slow diffusion was a result of poorly developed products or if there are external factors such as social or organisational aspects that caused this delay. Semi structured interviews were conducted with 15 informants who works with EDC systems daily and are professionals within this industry. The result indicates that the slow diffusion is partly caused by initially bad systems that in turn might have caused a resistance among the end users and partly caused by slow decision organisations such as multinational pharmaceutical companies. The advice given to the project owner who intends to acquire this market is to focus on electronic Patient Reported Outcome (ePRO), which is a tool used by individual patients for self-reporting of data in clinical trials. ePRO is an extension of the EDC systems and must be user friendly for the patients and easy to connect to other systems. The company should rather focus on small Contract Research Organisation (CRO) as main customers rather than Big Pharma. Big Pharma often conduct multinational studies and decisions regarding the protocol and how data is to be collected are centrally decided. Since the project owner is a newly started, small firm with limited experience of clinical trials my advice would be to target CROs that conduct smaller studies.
Place, publisher, year, edition, pages
2014. , 87 p.
Clinical Trials, Data Collection, Electronic Data Capture, Implementation
IdentifiersURN: urn:nbn:se:uu:diva-237406OAI: oai:DiVA.org:uu-237406DiVA: diva2:767804
Master Programme in Industrial Management and Innovation